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Nanotiv – Factor IX Concentrate

Nanotiv – Factor IX Concentrate. Plasma-derived, Very High Purity Factor IX Concentrate. Nanotiv – Factor IX Concentrate. Nanotiv is a highly pure factor IX concentrate derived from carefully selected donors and extensively tested plasma

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Nanotiv – Factor IX Concentrate

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  1. Nanotiv – Factor IX Concentrate Plasma-derived,Very High Purity Factor IX Concentrate

  2. Nanotiv – Factor IX Concentrate • Nanotiv is a highly pure factor IX concentrate derived from carefully selected donors and extensively tested plasma • The Nanotiv manufacturing process is designed to fulfil the highest modern requirements for virus safety by combining two reliable and validated methods of virus elimination • The Nanotiv manufacturing process is gentle, in order to preserve biological function of the factor IX, reduce the risk of thrombogenicity and lead to good clinical tolerance

  3. Carefully selected donors Controlled donation centres Extensive donation testing HBsAg Anti-HCV Anti-HIV ALT Syphilis PCR tests on Mini pools and Production pools Inventory holding Nanotiv – Rigorously Controlled Plasma

  4. Nanotiv Manufacturing Process Cryoprecipitate supernatant plasma Diafiltration Anion exchange chromatography Ultrafiltration S/D Virus inactivation Sterile filtration Affinity chromatography Lyophilisation Cation exchange chromatography NANOTIV Virus removal: Nanofiltration

  5. Nanotiv – Nanofiltration

  6. Nanotiv – Viral Safety: Conclusion • Nanotiv factor IX fulfils all current requirements for virus safety set out by regulatory bodies such as the Committee for Proprietary Medicinal Products* • Two effective steps against lipid enveloped viruses • One effective step against non enveloped viruses • A combination of methods based on different principles of action • Inactivation/removal with a high safety margin • Rapid virus inactivation • Robustness in the event of process variations • Validation of each step with a wide variety of viruses • An individual step efficacy equivalent to 4 log10 *CPMP/BWP/268/95, 1996. CPMP/BWP/269/95 rev 3., 2001

  7. Nanotiv Purity • Nanotiv is among the purest factor IX preparations available • Prothrombin complex factors are removed to trace amounts • The high purity of Nanotiv is the prerequisite for its excellent clinical tolerability and efficacy

  8. Nanotiv – In Vivo Thrombogenicity • High purity factor IX preparations, like Nanotiv are almost devoid of other vitamin K-dependent factors, as well as phospholipids • They are less likely to be thrombogenic, compared with products of low purity • Even at very high dose (200 IU/kg BW), Nanotiv still does not have an elevated thrombogenic effect

  9. Nanotiv – Clinical Efficacy, Pharmacokinetics Mean plasma concentration (IU/ml) vs. time (h), n = 12

  10. Nanotiv – Clinical Efficacy Pharmacokinetic Parameters

  11. Nanotiv – 6 Months Follow Up Study Number of injections per bleed vs. Cumulative % of bleeds managed % of bleeds Most bleeding episodes were managed using a single dose of (mean) 29 IU/kg BW

  12. Nanotiv – Clinical Efficacy Summary • In comparative pharmacokinetic studies, Nanotiv half-life and recovery values were within the normal range • After 6 months, the same cohort of patients showed similar values for half-life and recovery as at the beginning • Nanotiv gave no inhibitors • Most bleeding episodes were managed using a single dose of Nanotiv with a mean of 29 IU/kg BW • Nanotiv was well-tolerated

  13. Nanotiv – Clinical Efficacy in Surgery • Nanotiv was well-tolerated in surgery • At high bolus doses and in continuous infusion • The haemostatic effect always rated as good or excellent • No signs of thrombosis or pulmonary embolism observed • No adverse events observed • No inhibitors detected 14 days after conclusion of continuous infusion

  14. Water for Injections Alcohol swab x 3 Transfer needle Filter needle Syringe Infusion line (Butterfly) Gauze Plaster Nanotiv – Convenience: All You Need

  15. Nanotiv at a Glance – Key Features • Highly purified factor IX Triple chromatography process Specific activity ~ 200 IU/mg Gentle purification Non denatured • Heparin-free formulation Reduced risk of thrombocytopenia Minimal interference with diagnostic tests • Complementary virus safety concept High quality starting plasma Double virus elimination procedures Solvent / Detergent (S/D) treatment Nanofiltration Chromatographic steps provide additional safety

  16. Nanotiv at a Glance – In Daily Clinical Use • Extensive clinical experience Excellent general safety proven over more than 10 y Effective Well-tolerated • Convenient handling Small injection volume Easy documentation Pull-off labels Dissolves rapidly • Presentation • Storage and shelf-life 36 months shelf-life at + 4 °C to + 8 °C 1 month storage at elevated temperature up to 25 °C

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